Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05642156

Hemodynamics in Chronic Hemodialysis Patients Undergoing Isolated Ultrafiltration Compared to Conventional Hemodialysis

Led by Medical University of Graz · Updated on 2025-03-04

32

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Patients with end stage kidney disease undergoing hemodialysis face a high risk of cardiovascular problems and complications such as intradialytic hypotension (IDH), which can cause damage to the heart, brain, gastrointestinal system, and dialysis access. This study explores whether isolated ultrafiltration (iso-UF), a technique suggested to improve blood flow stability during dialysis, offers benefits compared to conventional hemodialysis. The study is randomized and aims to clarify the effects of iso-UF on hemodynamics and patient outcomes using modern dialysis methods. Participants will receive two treatment sequences: one involving sequential hemodialysis where isolated ultrafiltration is performed first followed by standard hemodialysis for eight sessions, then switching to conventional hemodialysis for another eight sessions; the other sequence reverses this order. The study seeks to measure changes in peripheral resistance, osmolality, cardiac output, and cardiac power index, as well as to assess dialysis quality and duration. Throughout the study, researchers will monitor the total peripheral resistance index over up to eight weeks. Participants will undergo dialysis sessions according to the study schedule while being assessed for hemodynamic stability and dialysis effectiveness. The study includes detailed cardiovascular monitoring to understand how the different dialysis methods impact blood flow and patient health, with safety and dialysis quality closely followed during the trial.

CONDITIONS

Brief Title

Hemodynamics in Chronic Hemodialysis Patients Undergoing Isolated Ultrafiltration Compared to Conventional Hemodialysis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Written consent of the participant after being informed
  • At least 18 years of age
  • End stage kidney disease patient undergoing hemodialysis
  • Dry weight stable for a minimum of one month
  • Interdialytic weight gain of >2 liters in the short interdialytic interval
Not Eligible

You will not qualify if you...

  • No informed consent was obtained
  • Patients with a pacemaker or implanted medical device that prevents compliance with study regulations
  • Patients treated with hemodiafiltration
  • Patients treated with medium cut-off membranes (Theranova, Baxter)
  • Patients with recurrent severe hyperkalemia after the short interdialytic interval (K+ concentration > 6.0 mmol/L, requiring more than 2 hours of dialysis to ameliorate the post-dialytic shift from other compartments)
  • Women of childbearing age not using contraception

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Approximately 8 weeks

Participants receive sequential hemodialysis first for 8 sessions and then switch to conventional hemodialysis for another 8 sessions, or vice versa, to assess differences in hemodynamic stability.

16 dialysis sessions in total

Trial Site Locations

Total: 1 location

1

Medical University of Graz

Graz, Austria

Actively Recruiting

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Research Team

A

Alexander H Kirsch

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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